evaluation of a combination of plants in anxiety-related sleep disorders: randomized trial versus placebo

Conditions: Sleep Troubles Associated With Anxiety

Summary: the objective of this double-blind randomized clinical trial is to compare the effects of a dietary supplement based on eschscholtzia and valerian extracts to a placebo after 28 days of supplementation, in subjects suffering from sleep troubles associated with anxiety.


Eligibility criteria:
inclusion criteria: * woman or man, aged of 18 to 65 years; * in good general health as evidenced by medical history and physical examination; * having at least 3 episodes of sleep disorders per week including one or more of the following: 1. difficulty falling asleep or 2. difficulty staying asleep or 3. poor quality sleep 4. waking up earlier than desired * the insufficient sleep duration and quality is coupled with a feeling of general fatigue; * sleep disorder last for more than 1 month; * presenting moderate to severe sleep disorder in the past month (isi ≥ 15); * with anxiety resulting in a ham-a score \> 8 and \< 25; * for women of childbearing age (women of childbearing potential, pre-menopausal or having postmenopausal amenorrhea of less than 12 months, and women who have not undergone surgical sterilization): 1. negative blood pregnancy test 2. acceptance to use an effective method of contraception, established for at least 1 month, and throughout the duration of the study; * fluent french speaking; * provision of signed and dated informed consent form; * stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: * a score \> 10 on the ess scale (that would correspond to serious hypersomnia); * sleep disorders secondary to another health problem (sleep apnea syndrome, narcolepsy-cataplexy, idiopathic hypersomnia, restless legs syndrome, chronic pain syndrome, ...) or an environmental factor (noise, light ...) or socio-professional (shift work, young child at home, people who are often jet lagged,... ); * severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia,...) or a severe neurologic trouble (alzheimer's, autism, parkinson's disease, ...); * subjects presenting severe gastro-intestinal, hepatic, respiratory, kidney or cardiovascular disorder or severe infection (e.g. hiv, hepatitis, ...); * acute or chronic somatic pathologies which can interfere with sleep: kidney cancer, etc.; * subjects with pre-menstrual syndrome or myasthenia gravis; * subjects who drink more than 2 glasses of alcohol per day (\> 20g of alcohol per day) or with exaggerated consumption of theine (≥ 1l per day) and caffeine-rich (≥ 800ml per day) beverages and energy drink (≥ 330ml per day); * smoker; * subject consuming drugs and/or with historical drug addiction; * under psychotropic treatment within the last month before screening (neuroleptic, anxiolytic, antidepressant, hypnotic, sedative, ...) or under current medication treatment which may alter the waking state (for example: cortisone, dopamine, amphetamine, antihistamines, beta-blockers, certain cough syrups, ....); * volunteer with suicidal risk according to the investigator; * under phytotherapy treatment or food supplement for sleep disorders within the last month before screening; * volunteer presenting current infection and/or fever; * volunteer with medical history of stroke or head trauma; * pregnant or lactating woman; * known allergy or intolerance to one product component (valerian, eschscholtzia or excipients); * subjects having participated to another clinical trial (with an investigational product) one month before the inclusion; * subjects that present alterations of their cognitive functions that will interfere with the comprehension of the study and procedures and/or with the completion of questionnaires; * vulnerable patient (deprived of liberty by judicial or administrative decision, under guardianship, curatorship or safeguard of justice, ...); * pharmacological resistance to common hypnotic/sedative drugs; * allergy/intolerance to the actimeter straps; * recent (\ 5kg, sport).